Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatment abt-199
Phase phase 1
Target BCL-2
Sponsor AbbVie
Collaborator Genentech, Inc.
Start date December 2013
End date July 2018
Trial size 12 participants
Trial identifier NCT01969695, M13-835

Summary

This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active and assigned to ABT-199 when the study was completed, may roll over into this extension study. Subjects will receive ABT-199 during this study.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
ABT-199 monotherapy
abt-199 GDC-0199
ABT-199 continuous once daily dosing

Primary Outcomes

Measure
Number of subjects with adverse events
time frame: Measured up to 2 years after the last subject has enrolled in the study
Percentage of subjects with adverse events
time frame: Measured up to 2 years after the last subject has enrolled in the study
Change in physical exam finding, including vital signs
time frame: Measured from Day 1 up to 2 years after the last subject has enrolled in the study
Change in clinical laboratory test results
time frame: Measured from Day 1 up to 2 years after the last subject has enrolled in the study
Change in cardiac assessment findings
time frame: Measured from Day 1 up to 2 years after the last subject has enrolled in the study

Eligibility Criteria

All participants from 18 years up to 99 years old.

Inclusion Criteria

  • Subject has completed a prior ABT-199 study (and had met the criteria for a diagnosis of NHL and all other eligibility criteria for the previous study) and the investigator believes that treatment with ABT-199 is in the best interest of the subject.

Exclusion Criteria

  • Subject discontinued ABT-199 administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
  • Subject has any medical condition that in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
  • Subject has not recovered to ≤ Grade 2 clinically significant adverse effect(s)/toxicity(ies) of previous therapy.
  • Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).

Additional Information

Official title An Extension Study of Venetoclax in Subjects With Advanced Non-Hodgkin's Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by AbbVie.